DOSAGE and Administration
OF MONJUVI + Lenalidomide1

Recommended dosage of MONJUVI and lenalidomide

  • MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage IRRs

  • The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule in the table below

  • Administer MONJUVI in combination with lenalidomide 25 mg orally on days 1 to 21 of each 28-day cycle for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity

  • Refer to the lenalidomide prescribing information for dosing guidelines and recommendations

Administration of MONJUVI

  1. Administer MONJUVI as an intravenous infusion.

    • For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then, increase the rate so that the infusion is administered within 1.5 to 2.5 hours

    • Administer all subsequent infusions within 1.5 to 2 hours

  2. Infuse the entire contents of the bag containing MONJUVI.

  3. Do not co-administer other drugs through the same infusion line.

  4. No incompatibilities have been observed between MONJUVI with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylenterephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.


The cycle length for MONJUVI is 28 days
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Cycle 1                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
Lenalidomide 25 mg daily
                                                         
Cycles 2 and 3                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
Lenalidomide 25 mg daily
                                                         
                                                         
Cycles 4 to 12                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
Lenalidomide 25 mg daily
                                                         
After 12 cycles, continue MONJUVI                                                        
monotherapy until disease progression                                                        
or unacceptable toxicity                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
                                                         
After 12 cycles, continue MONJUVI monotherapy until disease progression or unacceptable toxicity
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
                                                         

RECOMMENDED PREMEDICATIONS1

Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize IRRs. Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.

For patients not experiencing IRRs during the first 3 infusions, premedication is optional for subsequent infusions.

If a patient experiences an IRR, administer premedications before each subsequent infusion.

IRR=infusion-related reaction.


DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS1

Management guidelines for IRRs and myelosuppression

Infusion-related reactions (IRRs)  
Severity Dosage Modification
GRADE 2
(moderate)
  • Interrupt infusion immediately and manage signs and symptoms

  • Once signs and symptoms resolve or reduce to grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred

GRADE 3
(severe)
  • Interrupt infusion immediately and manage signs and symptoms

  • Once signs and symptoms resolve or reduce to grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred

  • If after rechallenge the reaction returns, stop the infusion immediately

GRADE 4
(life-threatening)
  • Stop the infusion immediately and permanently discontinue MONJUVI

Myelosuppression  
Severity Dosage Modification
Platelet count of
50,000/mcL or less
  • Withhold MONJUVI and lenalidomide and monitor CBC weekly until platelet count is 50,000/mcL or higher

  • Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications

Neutrophil count of 1,000/mcL or less for at least 7 days

OR

Neutrophil count of 1,000/mcL or less with an increase of body temperature to 100.4 °F (38 °C) or higher

OR

Neutrophil count less than 500/mcL
  • Withhold MONJUVI and lenalidomide and monitor CBC weekly until neutrophil count is 1,000/mcL or higher

  • Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to the lenalidomide prescribing information for dosage modifications

CBC=complete blood count.

Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.


HOW MONJUVI IS SUPPLIED1

  • MONJUVI (tafasitamab-cxix) for injection is a sterile, preservative-free, white to slightly yellowish lyophilized powder for reconstitution, supplied as a 200-mg single-dose vial

  • Each 200-mg vial is individually packaged in a carton (NDC 73535-208-01)


STORAGE AND HANDLING OF MONJUVI1

Store refrigerated at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. Do not shake. Do not freeze.

INTERACTIVE
TREATMENT CALENDAR

Create a customized dosing schedule for your patient

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MOA

View the mechanism of action for MONJUVI

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REFERENCE: 1. MONJUVI Prescribing Information. Boston, MA: MorphoSys.